MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DIMER; FIBRIN SPLIT PRODUCTS

Catalog Number 04912551190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).Unique device identifier (udi) (b)(4).The investigation reviewed the customer's calibration, qc, and system alarm trace and did not identify any abnormalities.The customer confirmed no patient sample was available for further investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable d-dimer results for one patient tested on a cobas 8000 c 502 module serial number (b)(4).On (b)(4) 2021, the patient's initial d-dimer result was not reported outside the laboratory.A sample from the patient was repeated on a "manual device" at a different laboratory, the date of measurement was requested but not provided.On (b)(6) 2021, a sample from the patient was tested on the same c 502 module.On (b)(6) 2021, the patient's initial d-dimer result was 8.6 ug/ml.The patient's d-dimer result at the different laboratory on a "manual device" was 0.7 ug/ml.On (b)(6) 2021, the patient's repeat d-dimer result on a c 502 module was 9.2 ug/ml with a data flag.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11759381
• MDR Text Key: 248425210
• Report Number: 1823260-2021-01300
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 04912551190
• Device Lot Number: 51964501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR